NDC Code(s) : 15014-145-50
Packager : Gentex Pharma

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Prodrin Isometheptene Mucate, Caffeine, and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15014-145
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOMETHEPTENE MUCATE(UNII: 8O120FDS6P)
(ISOMETHEPTENE - UNII:Y7L24THH6T) 		ISOMETHEPTENE MUCATE65 mg
CAFFEINE(UNII: 3G6A5W338E)
(CAFFEINE - UNII:3G6A5W338E) 		CAFFEINE20 mg
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONES(UNII: FZ989GH94E)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 11 mm
Flavor Imprint Code PRODRIN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:15014-145-5050 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/01/2010

PRINCIPAL DISPLAY PANEL

NDC 15014-145-50

PRODRIN

CAPLETS
Rx ONLY

Isometheptene Mucate ......................................... 65 mg

Caffeine ............................................................... 20 mg

Acetaminophen .................................................. 325 mg

Net Contents: 50 Caplets

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